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Completed

NCT Number: NCT02681484

Effects of Speech-therapy in Hypertensive Patients

Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study was performed to learn more about such improvements and possible alteration in baroreflex sensitivity (BRS) in hypertensive patients, which characteristically differ in those regulatory parameters from normotensive patients

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In this prospective, primarily pre-post study, patients received three ATS treatments in alternation with three control sessions (casual talking with the therapist). In order to perform HRV-analysis and BRS determination blood pressure and ECG were continuously recorded during the sessions. Changes in subjective well-being and perceived health were assessed by questionnaire before and after the various sessions (mood questionaire).

Thirty-one patients participated in this study, the majority diagnosed with arterial hypertension (22 out of 31).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for speech therapy
  • Willing and able to perform speech therapy
  • Out-patient treatment or planned hospitalisation for at least 14 days.
  • Diagnosed with hypertension (I 10, either on drug therapy or verified by 24h blood pressure measurements), with tension headache (G 44.2) or with anxiety (F 41) confirmed by the recruiting physician
  • No alteration in medication affecting HRV for the last 2 months before and during the study

Exclusion criteria

  • Comorbidity strongly influencing HRV
  • Too weak to participate in an active therapy
  • Pacemaker
  • Skin disease or allergies preventing the use of ECG electrodes

Treatment and study plan

Anthroposophic speech therapy

Behavioral

Anthroposophic speech therapy uses sound-combinations like "KLSFM" or "OM" and hexameter verse in German, spoken by the therapist and imitated by the patients, to expand and decelerate respiration. The intervention is conducted by the same qualified therapist for one patient in different days but during the same daytime for 30 minutes in upright position and walking.

Other names: Speech guided breathing therapy

Primary outcomes

  1. Change from pre-rest baroreflex sensitivity after intervention and resting.

    Time frame: 30min in total per session. Six sessions per patient in total.

    Baro reflex sensitivity via continuous blood pressure measurement by volume clamp method (non invasive)

Secondary outcomes

  1. Change from pre-rest heart rate variability after intervention and resting

    Time frame: Measurement over whole session (60min in total). Six sessions per patient in total.

    Heart rate variability measurements via portable ECG-recorder

Sponsors and collaborators

Lead sponsor

Klinik Arlesheim

Other

Collaborators

  • Paracelsus-Spital Richterswil
  • University of Bern

Registry information

Official study title

Speech Guided Breathing: a Modality to Influence Cardiovascular Regulation and Health Perception in Hypertensive Patients?

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Feb 12, 2016
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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